Safe Patient Project

Hip and Knee Replacement

More and more people are getting hip and knee replacements to feel better, play longer. And if the hip or knee implant fails, it likely will require revision surgery, which is both painful and costly. Implants don’t come with a warranty. Consumers Union is calling on the top manufacturers of hip and knee implants to begin offering warranties for their products and take responsibility for the associated costs if they fail due to a product defective.

Consumers Union Documents

The undersigned organizations represent healthcare providers, clinical researchers, public health experts, and consumer advocates. We are concerned that the proposed legislation as written fails to ensure a comprehensive and scientifically based approach that supports patients’ access to affordable treatments.

Consumers Union strongly supports the FDA’s proposed order to change the classification for surgical mesh used to repair transvaginal Pelvic Organ Prolapse (POP) from Class II to Class III. This change will require any future mesh product for POP to provide much needed clinical evidence demonstrating it is a safe and effective device before it is marketed for use in patients.

Consumers Union, the policy and advocacy division of Consumer Reports, is taking its campaign to convince medical device companies to provide warranties for hip and knee implants directly to the doctors who perform hundreds of thousands of these operations each year. The campaign has launched an ad campaign and will be conducting outreach activities this week during the American Association of Orthopaedic Surgeons (AAOS) conference in New Orleans.

Consumers Union, the policy arm of Consumer Reports, is calling on the top manufacturers of hip and knee implants to provide warranties that would entitle patients to have defective devices replaced at no cost.

Learn the Risks and Benefits of Any Drug You Take Taking a new medication is a big deal. When a doctor recommends a new prescription, you should walk away knowing why it was prescribed and how you should monitor your symptoms after taking it. The more informed you are as a patient, the easier it will Continue Reading

Consumers Union’s Safe Patient Project hosts a national gathering of patient safety activists from across the country to connect face-to-face, share information and strategize on future work together. This year November 11-13, we held our 9th summit in Yonkers, NY, headquarters of Consumer Reports.

A morcellator is a medical device that seems like it was developed in medieval times as an instrument of torture. But it is actually marketed and used to grind up tissue during laparoscopic hysterectomies and uterine fibroid removal. It becomes problematic if the tissue being shredded is cancerous. The FDA recently issued a safety alert stating, “Morcellating these tumors can spread cancerous tissue internally and significantly worsen the odds of long-term survival.

News Articles

Embedded in the language of the 21st Century Cures Act are some good ideas that could streamline the development and evaluation of new drugs and devices; its call for increased NIH funding may prove to be its most useful component. But political forces have also introduced other provisions that could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit.

“Patients and physicians would not benefit from legislation that instead of catapulting us into the future, could actually bring back some of the problems we thought we had left behind in the 20th century.

This system of filing these (MDR) reports is the only thing in place that can tell us that devices are having problems, (and) … it often puts the interests of (device) manufacturers and the hospitals ahead of the public,” says Lisa McGiffert, who heads the Safe Patient Project at Consumers Union, the publisher of Consumer Reports. “It’s a pretty weak system.”

Summary from John James: “The devastation wrought by hurricane Sandy leaves us full of empathy for those who lost loved ones and homes. When disaster unfolds suddenly, we notice it as the news media graphically magnifies the events on our TVs. The disaster that comprises much our medical industry quietly unfolds as medical errors occur in hospitals spread across the nation, and no one is there to produce graphic images of the death and suffering. In an attempt to display some of the suffering, my November newsletter begins with a review of the book “Unaccountable” by Marty Makary, MD. I was not fully aware of the endemic nature of the dangers lurking in hospitals.

The first two articles deal with medical errors – the first on diagnostic errors and the second on errors of omission. On page 3 I take a look at recent misdeeds of big Pharma, and then deal with ethical issues associated post-marketing drug testing on patients. A business model suggests that providers should start giving us what we really want – health – not medical care. Finally, we have a look at why hospital prices continue to escalate. I hope you find these stories informative.”

Summary from John James: “These are frustrating days in our country because it seems that anyone left in the middle ground on major political issues is rare, or at least they dare not speak. As we chide Congress for its ineptness, we must acknowledge that we put those people there, and in most cases they reflect what we want.

This month I was honored to have my new estimate of harm to hospitalized patients, which was published in the September issue of the Journal of Patient Safety (http://journals.lww.com/journalpatientsafety/pages/articleviewer.aspx?year=2013&issue=09000&article=00002&type=abstract), picked up Marshall Allen of Pro Publica (http://www.propublica.org/article/how-many-die-from-medical-mistakes-in-us-hospitals). He brought validity to my estimate by asking MDs in the patient safety community what they thought of my work. I have marked his and other sources that wrote about the new estimate with an asterisk in my “SitesLinks” collection this month. There are many examples of medical care gone bad.

October’s newsletter deals with 1) over-diagnosis of mental illness, 2) the secrets of the medical industry, 3) how unintended consequences can occur when physician performance is measured, 4) the death toll on women from painkillers, 5) the need to stop calling so many things cancer, and 6) the issues associated with high blood pressure and too much sodium.”

John James’ summary: “Young children often grow up in a world where everything is about their needs, both perceived and real. Wise parents work against this self-centered worldview so that by the time children become adults, they understand that they are not the center of the universe. There is one circumstance where this view must be discouraged – medical care. When receiving medical care you should be the center of all that can be reasonably done for your wellbeing – with you giving informed permission for anything invasive.

In reality, medical care, although headed in the direction of patient-centered care, has a long way to go. My newsletter’s first article demonstrates this reality. The second suggests that intense care is not usually patient-centered for critically ill patients; furthermore, the money we spend on medical care can be misspent, in part due to the fee-for-service scheme that doctors prefer. The third article describes how stress from medical bills can become pervasive, especially for the uninsured.

The fourth article slams the FDA for not enforcing a law that requires drug makers to do additional testing of their drugs, and a fifth criticizes Congress for not requiring stronger control of compounding companies. The newsletter ends with an article on regulating those who could misinterpret images, and with another article on cancer-drug makers who downplay the side effects of their potent products.”

Subtopics

Activists

The mission of Washington Advocates for Patient Safety (WAPS) is to promote accountability, quality, safety, and responsibility in patient care. As the voice of patients, their goals are to eliminate medical errors and harm and to save more lives.

In October of 2008, Terri wanted to become involved in her state’s special election in a real way. With each passing day, she became angrier about the TV ads the drug companies were constantly running to defeat real drug price reform…

Stories about Hip and Knee Replacement

What I would expect from a good warranty: 1- Description of all types of risks involved for health and safety 2- Lists of symptoms of failure of the device for use with doctors who may have to treat device failures and health harms. 3- Lists of suitable and approved medical tests, imaging, blood tests, fluid Continue Reading

What I would expect from a good warranty: I expect the company to stand behind their product. I understand that it’s impossible to guarantee great results for every person so the warranty should cover any product defects including the proper model for each individual. Anthony’s story: My hip replacement occurred 3 years ago. They used Continue Reading

To Delay is Deadly

98,000 people die each year needlessly because of preventable medical harm. Efforts to reduce this are few and fragmented. With little transparency and no public reporting (except where hard fought state laws now require it), scarce data does not paint a picture of real progress.

In this report (PDF)
we give the country a failing grade on progress on select recommendations we believe necessary to create a health-care system free of preventable medical harm.

Glossary

Medicare keeps costs down through broad spreading of risks throughout the large pool of covered persons, coupled with universal participation. Other essential elements of the program include freedom of choice of doctor, accountability for high quality of care, and fair payment to health care providers to ensure broad participation. Areas for improvement in Medicare include limitations on out-of-pocket costs, a buy-in program for people aged 55 -65, and giving the program the ability to negotiate lower prescription drug prices.